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Remodulin Warnings, Precautions, Pregnancy, Nursing, Abuse - Treprostinil sodium

Remodulin Warnings, Precautions, Pregnancy, Nursing, Abuse - Treprostinil sodium

WARNINGS

Remodulin is indicated for subcutaneous use only.

PRECAUTIONS

General

Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.

Remodulin is a potent pulmonary and systemic vasodilator. Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Subcutaneous therapy with Remodulin may be used for prolonged periods, and the patient’s ability to administer Remodulin and care for an infusion system should be carefully considered.

Dose should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacological effects or for unacceptable infusion site symptoms (see DOSAGE AND ADMINISTRATION).

Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided.

Information for Patients

Patients receiving Remodulin should be given the following information: Remodulin is infused continuously through a subcutaneous catheter, via an infusion pump. Therapy with Remodulin will be needed for prolonged periods, possibly years, and the patient's ability to accept, place, and care for a subcutaneous catheter and to use an infusion pump should be carefully considered. Additionally, patients should be aware that subsequent disease management may require the initiation of an intravenous therapy.

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